(88 days)
The Antlia III™ Wound Treatment System is indicated for the application of suction (negative pressure) to wounds as it may promote wound healing and for the removal of fluid, including wound exudates, irrigation fluids, body fluids and infectious materials.
The Antlia III™ Wound Treatment System is an AC-powered, portable suction device with battery backup that provides localized negative pressure when used with the ITI Dressing to remove fluid and infectious materials from the wound as it may promote wound healing. It is intended for use on patients who would benefit from a suction device, particularly as the device may promote wound healing, including patients who would benefit from vacuum assisted drainage and removal of infectious material, irrigation fluids or other body fluids from wounds.
The Antlia III™ Wound Treatment System consists of the same powered suction pump components and functions the same as the Antlia II Suction Pump device, only housed in a smaller, lighter weight plastic enclosure with a built-in placement holder for the ITI 300cc and 500cc collection canisters, and optional pressure settings of -50mmHg, -75mmHg, -100mmHg, - 125mmHg, and -150mmHg.
Based on the provided text, the document describes a 510(k) submission for the Antlia III™ Wound Treatment System, a medical device. The information provided heavily pertains to substantial equivalence and safety and electrical testing, rather than a clinical performance study of an AI/algorithm-based device.
Therefore, I cannot fulfill most of your request as the provided text does not contain the information related to an AI/algorithm-based device's validation study including:
- Acceptance criteria for an AI/algorithm's performance (e.g., sensitivity, specificity, AUC)
- Sample sizes for test sets (beyond general product testing)
- Data provenance for clinical images/data
- Number of experts for ground truth establishment or their qualifications
- Adjudication methods
- MRMC studies or effect sizes for AI assistance
- Standalone algorithm performance
- Type of ground truth (e.g., pathology, outcomes data) for clinical performance
- Training set details (sample size, ground truth establishment)
The document focuses on demonstrating that the Antlia III is substantially equivalent to a predicate device (Antlia II) based on:
- Similar technological characteristics and function: It's described as having the same powered suction pump components and functions, just in a smaller, lighter enclosure with optional pressure settings.
- Non-clinical tests: IEC 60601-1 for electrical safety and IEC 60601-1-2 for electromagnetic compatibility were conducted.
- Verification and Validation activities: These were performed based on risk analyses for the device modifications, and it's stated that "predetermined acceptance criteria were met." However, the specific criteria and performance results are not detailed in the summary provided. They refer to the full V&V documentation which is not included here.
In summary, the provided text describes a submission for a physical medical device (negative pressure wound therapy system), not an AI/algorithm-based device. Hence, the requested parameters for an AI device's validation study are not applicable or present in this document.
If you were expecting information on an AI device, please provide the relevant documents for such a device.
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510(k) Summary
AUG - 8 2011 Antlia III™ Wound Treatment System
| 1. | Name/Address of Submitter: | Innovative Therapies, Inc.12 Meem Ave., Suite CGaithersburg, MD 20877 |
|---|---|---|
| 2. | Contact Person: | Judith HarbourDirector, Regulatory and Quality866.484.6798 x 105 |
| 3. | Date Summary Prepared: | April 29, 2011 |
| 4. | Name of Device: | Antlia III™ Wound Treatment System |
| • Trade name: | Negative Pressure Wound Therapy andWound Dressing kit | |
| • Classification Name: | Powered Suction Pump21 CFR 878.4780Class II; Product Code: OMP |
6. Description of Device
The Antlia III™ Wound Treatment System is an AC-powered, portable suction device with battery backup that provides localized negative pressure when used with the ITI Dressing to remove fluid and infectious materials from the wound as it may promote wound healing. It is intended for use on patients who would benefit from a suction device, particularly as the device may promote wound healing, including patients who would benefit from vacuum assisted drainage and removal of infectious material, irrigation fluids or other body fluids from wounds.
The Antlia III™ Wound Treatment System consists of the same powered suction pump components and functions the same as the Antlia II Suction Pump device, only housed in a smaller, lighter weight plastic enclosure with a built-in placement holder for the ITI 300cc and 500cc collection canisters, and optional pressure settings of -50mmHg, -75mmHg, -100mmHg, - 125mmHg, and -150mmHg.
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7. Indication for Use
The Antlia III™ Wound Treatment System is indicated for the application of suction (negative pressure) to wounds as it may promote wound healing and for the removal of fluid, including wound exudates, irrigation fluids, body fluids and infectious materials.
8. Technological Characteristics of the device
The Antlia III™ Wound Treatment System Unit is smaller in size and weighs less compared to the predicate Antlia II powered suction pump, yet has the same technological characteristics and functions as the Antlia IITM Suction Pump System.
9. Summary of Non-clinical tests conducted for Substantial Equivalence
Testing in accordance with IEC 60601-1 was conducted for electrical safety.
Testing in accordance with IEC 60601-1-2 was conducted for electromagnetic compatibility.
Verification and Validation activities, as required by the risk analyses for the Antlia III device modifications, were performed and demonstrated that the predetermined acceptance criteria were met.
10. Conclusion
Testing demonstrates that the Antlia III™ Wound Treatment System is substantially equivalent to the predicate device in terms of safety and effectiveness and has the same indications and intended use and same technological features of Antlia II.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Innovative Therapies, Inc. % Ms. Judith Harbour Director, Quality and Regulatory Affairs 12 Meem Avenue, Suite C Gaithersburg, Maryland 20877
- 8 2011 દ્યાઉ
Re: K111333
Trade/Device Name: Antila III™ Wound Treatment System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: II Product Code: OMP Dated: July 14, 2011 Received: July 15, 2011
Dear Ms. Harbour:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Ms. Judith Harbour
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor_You/Industry/default.htm.
Sincerely yours,
For Rob
Lir
Deror
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): KIII 333
Device Name: Antlia III™ Wound Treatment System
Indications for Use:
The Antlia III™ Wound Treatment System is indicated for the application of suction (negative pressure) to wounds as it may promote wound healing and for the removal of fluids, including wound exudates, irrigation fluids, body fluids and infectious materials.
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Si
(Division Sign-Off) Division of Surgical, Orthor and Restorative Devices
510(k) Number K111333
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.